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Research Report
Ibogaine: A Comprehensive Analysis of its Development by ATAI Life Sciences and DemeRx for Substance Use Disorders
I. Executive Summary
Ibogaine, a psychoactive indole alkaloid derived from the Tabernanthe iboga plant, has a long history of traditional use in West African spiritual practices and has garnered significant interest for its potential in treating substance use disorders (SUDs). This report provides a comprehensive analysis of ibogaine and its metabolite noribogaine, focusing on the development programs led by DemeRx, Inc. and its collaboration with, and subsequent program acquisition by, ATAI Life Sciences.
The primary therapeutic focus for ibogaine (as DMX-1002) has been Opioid Use Disorder (OUD), driven by anecdotal evidence of its ability to interrupt addiction and alleviate withdrawal. Noribogaine (as DMX-1001), an active metabolite, is being developed by DemeRx for Alcohol Use Disorder (AUD), with a rationale centered on retaining therapeutic benefits while potentially mitigating ibogaine's psychedelic effects and safety concerns.
The DMX-1002 program, under ATAI Life Sciences, completed a Phase 1 trial (NCT05029401) which, while meeting pharmacokinetic endpoints, highlighted QTc prolongation as a significant safety signal. Despite initial plans to advance to Phase 2a, DMX-1002 has been conspicuously absent from ATAI's recent pipeline updates, suggesting a strategic deprioritization or discontinuation, likely influenced by the safety profile and regulatory complexities associated with a Schedule I substance.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/08/31 | Phase 1 | Completed | |||
2019/07/01 | Phase 2 | Completed | International Center for Ethnobotanical Education, Research, and Service | ||
2017/12/21 | Phase 2 | Completed |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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